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FDA approves new application for Exact Imaging's ExactVu micro-ultrasound

por Lauren Dubinsky , Senior Reporter
Exact Imaging’s new FusionVu application has been cleared by the FDA for use on its ExactVu micro-ultrasound system.

“Unlike other MR fusion systems, the ExactVu/FusionVu combination is one instrument that provides the highest resolution real-time imaging and targeting,” Randy AuCoin, president and CEO of Exact Imaging, told HCB News.

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The ExactVu ultrasound has spatial resolution down to 70 microns, which enables the urologist to see detailed changes in the prostatic tissue and distinguish suspicious and benign lesions. It also gas such high real-time resolution that the urologist can interrogate the prostate during the procedure and update targets based on what the screen shows.

“When a patient has repeated biopsies with negative results but with rising indications, the guidelines would suggest the need for a prostate MR,” said AuCoin. “As such, FusionVu provides micro-ultrasound to guide the targeted biopsies and the reference of the MR to ensure that all targets on both modalities are identified and targeted.”

It only takes 10 to 15 minutes to perform a targeted biopsy on the ExactVu system. It’s also cost effective, as there are no associated MR costs because the targeting is done with native micro-ultrasound in the physician’s office.

“ExactVu system by itself uses the standard urologist biopsy protocol and workflow, but enables resolution, tissue characterization and targeting that is only otherwise available on MR fusion,” said AuCoin. “When using FusionVu, outside of acquiring the prostate MR, which is similar for all platforms, the alignment and targeting of suspicious regions is very easy and fast with the ExactVu platform.”

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